Study design and setting-
This is an experimental study evaluating the effect of Aerobic exercises combined with Music Therapy on the fatigue and quality of life in female with thyroidectomy following thyroid cancer. The participants would be recruited from Acharya Vinoba Bhave Rural Hospital in Sawangi Meghe, Wardha, Maharashtra, after receiving approval from the Institutional Ethics Committee of Datta Meghe Institute of Medical Sciences, which is considered a university. The participants were informed of the study's objectives, and they were required to sign a consent letter.
Inclusion criteria: -
- Female gender
- Age range: 20 to 55 years
- Those who are fatigue and poor quality of life after thyroidectomy following thyroid cancer.
Exclusion criteria: -
- Those who have an unstable cardiovascular condition, as determined by the physician
- Those who are currently enrolled in another clinical trial
- Those who have chronic, progressive medical condition
- Those who have an ongoing pregnancy
Before randomization subjects will be assessed using the questionnaire which will be self-drafted. Information regarding age, occupation, primary symptoms, additional symptoms, duration of symptom, history of recurrence, history of previous treatment, quality of life will be obtained from an interview which will contain a series of standard questions.
Sample Size Calculation: -
The number of patients participating in the study is determined by SPSS 27. OV software using data of Cochran, W.G. (1977). 30 patients will be enrolled in the study.
The diagnosed case of thyroid cancer who underwent thyroidectomy in the study was enrolled. After enrolling in the study, participants will participate in a 6-week rehabilitation program. Before allocation, informed patient consent will be obtained once the study's purpose, technique, advantages, and post-intervention effects have been explained.
Thirty women with thyroid cancer who underwent thyroidectomy were included in this study. The study's goal will be described, and participants' informed consent will be obtained. First, we collected demographic information of the patients. For treatment, the patients have to visit six weeks and in one week four days. The participants will be given the questionnaires- Fatigue assessment scale and the Rand SF-36 Questionnaire. Cancer related fatigue will be evaluated by using Fatigue assessment scale and Quality of life will be evaluated by using the Rand SF-36 questionnaire, pre and post-intervention. The therapy goals in women who underwent thyroidectomy includes reducing fatigue, improving general well-being and quality of life. Patients received an exercise programme rehabilitation include sessions, four times a week for the duration of 6 weeks, consisting of 10 minutes of warm up and cool down exercise and 20 minutes of aerobic exercises combined with music therapy. Each session consists of 40 minutes. The aerobic exercises that was implemented included 20 minutes of walking combined with Music therapy.
The patients will complete outcome measures such as Fatigue assessment scale and Rand SF-36 Questionnaire.
- Fatigue assessment scale- It is a self-reported 10-item scale for assessing chronic fatigue symptoms. This scale showed good validity and reliability in a number of cancer patients. Total scores can range from 10 to 50, with 10 indicating the least amount of fatigue and 50 indicating the most.
- Rand SF-36 Questionnaire – The RAND-36 (SF-36) is the most extensively used health-related quality-of-life scale in use today. It is a 36-item questionnaire that evaluates eight different aspects of health: physical functioning, role limitations due to physical health problems, role restrictions due to emotional disorders, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
DATA COLLECTION AND STATISTICAL ANALYSIS:
The study’s data would be obtained from an excel spreadsheet. The study's findings will be kept in a safe database. In the study setting, the assessment forms, informed consent letter signed by the patients, filled questionnaires, and other information will keep safe. Under the direction of the chief investigators, data will be collected and reported. The accuracy of the analytical documentation will be checked twice. An Excel spreadsheet has been prepared for publication after the study is completed. Data from the trial will be kept in a secure safe with limited access for later analysis by a biostatistician and the lead researcher. To avoid data loss, checklists are utilised. The Chi-square test and the unpaired t-test will be used to analyse statistical data in the data analysis. The SPSS 27. OV latest version will be used to perform statistical analyses. Tests should be performed with a 95 percent confidence interval (p-value 0.037).